Performance Qualification Protocol for sterilizing and depyrogenating tunnel Dry Powder Injection Production area. Qualification (PQ) of Sterilizing and Depyrogenating Tunnel 1.0 Objective: The purpose of this protocol is to provide…
The term “Quality Metrics” means all those indicators that give an idea of the collective quality characteristics of a certain production site. The number of rejected batches per year compared…
Guideline (SOP) to provide guidance for activities and analyses performed by Microbiology and Environmental Monitoring personnel in support of Aseptic Process Simulations (APS), also referred to as Media Fill Test.…